Covidien Announces Study Results Demonstrating Benefits of Minimally Invasive Surgery over Traditional Open Procedures

Separate video presentation shows feasibility of removing a part of a patient’s colon through a single incision

NEW HAVEN, Conn.--(BUSINESS WIRE)-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced results of a retrospective data analysis involving more than 93,000 patients that demonstrate the benefits of laparoscopic surgery over open procedures. A separate video presentation by a colorectal surgeon showed the feasibility of single-port laparoscopic colorectal surgery.

Both presentations were made at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), which took place March 7-10 in San Diego, CA.

Laparoscopic Surgery Study

Results of the data analysis revealed that laparoscopic surgery was associated with a decreased risk of blood transfusions and fewer surgical site infections, when compared to open surgery. The analysis also noted that laparoscopic procedures cost significantly less, on average, than open approaches.

“This robust analysis confirms that minimally invasive, laparoscopic surgery is a strong alternative option to open surgery, with demonstrably better clinical outcomes and cost benefits for the patient across a variety of surgical procedures,” said primary investigator Santosh Agarwal, Senior Specialist, Healthcare Economics, at Covidien, whose team presented the topline results of the study (Abstract P559).

The investigators evaluated data from patients undergoing common surgical procedures, including appendectomy, cholecystectomy, colectomy and gastric bypass.

Open procedures were associated with a 108 percent increased risk of blood transfusions and a 174 percent increased risk of surgical site infections, as compared to laparoscopic procedures.1 On average, open surgery increased total costs by $3,566 per case and added 2.25 days to each patient’s hospital stay, compared to similar laparoscopic cases. After risk adjustment, each 30-minute interval increase in OR time added $1,456 in total costs and 0.31 days in the hospital in addition to a 21 percent higher risk of blood transfusion and a 20 percent increased risk of surgical site infections.

“Years of clinical data from thousands of patients undergoing varying forms of minimally invasive surgery consistently highlight improved patient outcomes and cost efficiencies with this approach,” said Michael Tarnoff, MD, Global Chief Medical Officer, Covidien. “Covidien is dedicated to continuously improving surgical device technology. Our goal is to develop innovative tools designed to reduce the surgical footprint leading to reduced convalescence and lower overall healthcare costs.”

Colorectal Surgery

Daniel P. Geisler, MD, of the West Penn Allegheny Health System in Pittsburgh, presented a video (Abstract V022)2 highlighting the feasibility of removing a part of a patient’s colon through a single incision. In the video, Dr. Geisler performed low anterior resection to remove a suspected cancerous tumor that was less than 2 cm through the SILS™ Port placed in the navel. He used the LigaSure™ 5 mm blunt tip sealer/divider instrument from Covidien for all mesenteric dissection, colon and small bowel mobilization and vessel sealing.

Dr. Geisler localized the tumor with lower endoscopy, then transected the rectum with Covidien’s Endo GIA™ 45 mm articulating medium/thick reload with Tri-Staple™ technology. He then exteriorized the bowel to remove the suspicious lesion and reattached the colon.

“Due to recent technical advances in instrumentation and an increased interest in exploring the feasibility of even less invasive surgical procedures, single port laparoscopic colorectal surgery is quickly gaining acceptance,” Dr. Geisler said. “Patients with chronic illnesses, such as ulcerative colitis or Crohn’s disease, often have to endure multiple invasive procedures, so surgeons are evaluating methods that remain clinically effective while reducing the recovery burden for patients. In this case, which was part of a larger 102-patient study, we demonstrate that, with proper training, it’s possible to resect the colon through a single incision. However, further studies are needed to assess the benefits of single port colorectal surgery over a conventional laparoscopic approach.”

Highlighted Products:

SILS Port

The SILS Port is an advanced surgical product designed by Covidien to allow laparoscopic surgery through a single incision. This product enables surgeons to use multiple instruments with maximal maneuverability through a single incision in the patient’s umbilicus (belly button). The SILS Port leaves a hidden scar when used in the umbilicus.

LigaSure Vessel Sealing Devices

LigaSure devices provide a unique combination of pressure and energy to permanently seal vessels up to and including 7 mm in size, lymphatics and tissue bundles. The average seal cycle is 2 to 4 seconds and seals withstand three times normal systolic blood pressure. The feedback-controlled response system automatically discontinues energy delivery when the seal cycle is complete, eliminating the guesswork. LigaSure technology has been used in millions of procedures worldwide and is supported by an ever-growing body of evidence-based research, now totaling over 300 published peer-reviewed studies.

Endo GIA Reloads with Tri-Staple Technology

Covidien designed its proprietary Tri-Staple technology for advanced tissue management in endoscopic stapling. The first-of-its-kind technology features intelligent compression with a graduated design to enhance staple line security. This allows surgeons to use Endo GIA Reloads with Tri-Staple technology confidently across a wide variety of laparoscopic procedures. Clinical field tests support use of the new Endo GIA reloads with Tri-Staple technology and the new Endo GIA Ultra handle in thoracic, bariatric, colorectal, general, hepatobiliary and gynecological surgery.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

1 Agarwal S, Minshall M, Cosgriff, N, Segan R, Delhougne G. The Impact of Minimally Invasive Surgery (MIS) and Operating Room (OR) Time on Blood Transfusions and Surgical Site Infections. Poster session presented at: Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons; 2012 Mar 7-10; San Diego, CA.

2 Geisler D. V022 Single incision laparoscopic anterior resection for rectal cancer. Video presented at: Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons; 2012 Mar 7-10; San Diego, CA.



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